NHLBI Policy for Inclusion of Women and Minorities in Clinical Research

 

PURPOSE

The NIH Revitalization Act of 1993 requires that women and members of minority groups and their subpopulations be included in all NIH-supported biomedical and behavioral research projects involving human subjects. Published NIH guidelines are intended to ensure that all such research is carried out in a manner sufficient to elicit information about individuals of both genders and the diverse racial and ethnic groups that constitute the U.S. population and, in the case of clinical trials, to examine differential effects on such groups.

DEFINITIONS

Refer to NHLBI Clinical Research Guide Glossary

POLICY DETAILS

Prior to making awards, the NHLBI will examine each grant application to ensure that it complies with the NIH Revitalization Act of 1993. The expectation for NHLBI-funded studies is that the targeted study population will reflect the composition of the overall U.S. population (51 percent women, 30 percent minorities) or the gender/race/ethnic distribution of the population affected by the disease/condition under study, if such information is available. Exceptions are permitted only when a valid scientific justification for limited inclusion exists; the law states explicitly that cost is not a permissible justification.

REFERENCES

CONTACT

Katie Kavounis, MPH
National Heart, Lung, and Blood Institute
6701 Rockledge Drive, Room 8125
Bethesda, MD  20892
Tel:  301-594-1369
Email: katherine.kavounis@nih.gov

Last Updated: November 9, 2016

For questions and/or concerns regarding the content of this page, please contact the Clinical Research Policy Manager